Quality Assurance Manager

About the Role

Our client is seeking a diligent and experienced Quality Assurance Manager to oversee quality systems and compliance initiatives within their pharmaceutical manufacturing operations in Southampton . This role is critical for ensuring that all products meet stringent quality standards and regulatory requirements. You will lead a team of QA professionals, implement robust quality management systems, and drive continuous improvement across all manufacturing processes. This is an excellent opportunity for a quality expert to make a significant impact on product integrity and patient safety.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with GMP and relevant regulatory standards.
• Oversee and conduct internal audits, supplier audits, and participate in regulatory inspections.
• Manage the deviation, CAPA (Corrective and Preventive Actions), and change control systems.
• Ensure all manufacturing processes and documentation comply with regulatory guidelines (e.g., FDA, EMA).
• Lead and mentor the Quality Assurance team, fostering a culture of quality awareness and continuous improvement.
• Review and approve batch records, validation protocols, and other critical quality documents.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Engineering, or a related scientific field.
• Minimum of 8 years of experience in Quality Assurance within the pharmaceutical or biotech industry.
• In-depth knowledge of GMP, ISO standards, and regulatory requirements for pharmaceuticals.
• Proven experience in managing audit programs and regulatory inspections.
• Strong leadership, problem-solving, and decision-making abilities.
• Excellent understanding of manufacturing processes, validation, and quality control principles.

Benefits

• Competitive salary and comprehensive benefits package.
• Opportunity to lead and shape the quality function in a key manufacturing site.
• Pension scheme and life insurance.
• Professional development and training opportunities.
• On-site parking and access to local amenities.